Label: MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY - menthol patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 06/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient                                                                                Purpose

    Menthol 5%..........................................................................Topical analgesic

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  • PURPOSE

    Uses Temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • bursitis
    • tendonitis
    • muscle strains
    • muscle sprains
    • bruises
    • cramps
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  • WARNINGS

    Warnings For external use only

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  • WHEN USING

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged skin
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  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • skin irritation develops
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • INDICATIONS & USAGE

    Directions

    • adults and children 12 years of age and older
    • carefully peel off protective backing from patch and apply sticky side to affected area
    • may be worn up to 8 hours
    • do not use more than 3 times a day
    • children under 12 years of age consult a doctor
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  • STORAGE AND HANDLING

    Other information

    • store at room temperature, not to exceed 86°F (30°C)
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  • INACTIVE INGREDIENT

    Inactive ingredients 1,3-butlene glycol, aloe vera (powder), metacrylic acid butlacrylate copolymer, dibutylhydroxytoluene, disodium edetate, d-sorbitol solution, gelatin, glycerine, kaolin, light liquid paraffin, magnesium aluminium hydrate, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium oxide, tocopherol acetate

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  • DOSAGE & ADMINISTRATION

    Distributed By:

    Major Pharmaceuticals

    31778 Enterprise Drive

    Livonia, MI 48150

    Made in Korea

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  • INGREDIENTS AND APPEARANCE
    MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY 
    menthol patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0904-5694
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 750 mg
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLENE GLYCOL  
    ALOE VERA LEAF  
    EDETATE DISODIUM  
    GELATIN  
    GLYCERIN  
    KAOLIN  
    LIGHT MINERAL OIL  
    METHYLPARABEN  
    POLYSORBATE 80  
    WATER  
    SODIUM POLYMETAPHOSPHATE  
    SORBITAN MONOOLEATE  
    TARTARIC ACID  
    TITANIUM DIOXIDE  
    ALPHA-TOCOPHEROL ACETATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-5694-01 1 in 1 PACKAGE
    1 5 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 06/30/2013
    Labeler - Major Pharmaceuticals (191427277)
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